Wie entstehen Normen? die Revision der ISO 9000-Familie · Folie 2 - 05/07 die Revision der ISO 9000-Familie Dipl.-Ing.(FH) Olaf Stuka, DGQ-Regional • gemeinnützig und unabhängig

Wie entstehen Normen?Wie entstehen Normen?die Revision der ISO 9000die Revision der ISO 9000--FamilieFamilie

Regionalkreis Hamburg, 08. Mai 2007Regionalkreis Hamburg, 08. Mai 2007

Folie 2 - 05/07 die Revision der ISO 9000-Familie Dipl.-Ing.(FH) Olaf Stuka, DGQ-Regional

• gemeinnützig und unabhängig seit 1952• Wir informieren und qualifizieren in

Qualitäts- und Umweltmanagement / Arbeitssicherheit(ca. 20.000 Teilnehmer im Jahr)

• Wir arbeiten aktiv in der internationalen Normung mit

• Wir regen zur interdisziplinärer wissenschaftlicher Forschung an

• Wir informieren über neueste Erkenntnisse aus den Bereichen Qualität, Umwelt, Arbeitssicherheit in Form von Fachliteratur, Tagungen und Workshops

• Wir sind nach DIN EN ISO 9001 zertifiziert und als Personalzertifizierernach DIN EN 17024 akkreditiert

Kompetenz braucht eine starke Basis


• Regionale Präsenz:- über 60 Regionalkreise bundesweit- vier Landesgeschäftsstellen(500 Veranstaltungen, 13.000 Teilnehmer

• Gemeinschaftsarbeit:Fachleute aus allen Wirtschaftszweigen engagieren sich in Arbeitsgruppen(über 70 Titel)

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Netzwerk der Qualität


Inhalt

• Ihre Erwartung an die Systemnormung• Was kann Normung leisten?• Stand der Systemnormung• Organisation der internationalen Normung• Aufbau des TC 176• Aufbau des deutschen Spiegelgremiums• Welche Dokumente werden einer Revision

unterzogen?


Erwartung an die Systemnormung

???

verständlichLeicht umsetzbar

kohärentkonsistent

praxisnah unterstützend

problembezogen

Vielseitig anwendbar

verfügbar


Was kann Normung leisten?

• Prinzipien

– Geplante Vereinheitlichung von materiellen und nichtmateriellen Gegenständen zum Wohl der Gesellschaft, die durch die interessierten Kreise gemeinsam durchgeführt wird

– Normung darf nicht zu wirtschaftlichen Vorteilen für eine besondere Gruppe führen

– Sie soll die Rationalisierung und die Qualitätssicherung in allen Sektoren von Wirtschaft; Technik und Wissenschaft und Verwaltung fördern

(nach DIN 820:94.04)


Sektor D

AbstraktionsgradNorm

Sektor C Sektor BSektor A

Interessierte Gruppen / Anwender

Der Normungsprozess


Normatives Dokument

Norm Technische Spezifikation Anweisung

Gesetze

Geografisch bestimmt

Vornorm

Grund-normen

Terminologisch

Prüf-normen

Produkt-normen

System-normen

Qualitäts-Management

(DIN EN 45020:98.07)

Arten normativer Dokumente


Normenskala der EU

Europäische harmonisierte Norm „EN“

Nationale angepasste europäische Norm

Andere nationale Normen der Mitgliedsländer der EU

Ergänzende Spezifikationen der Vertragspartner (Sektoren)

Verbindlichkeit


ISO 9004

ISO 10012

ISO 19011ISO 9000ISO 9001

ISO 9000 - Familie

Serie ISO 10000

TS 16949 IWA 1 IWA 2 IWA 3 ÍWA 4


ISO 9000

ISO 9000 - Familie

ISO 10005

ISO 10006

ISO 10007

ISO 10019

DIS ISO 10001

ISO 10002

DIS ISO 10003

TR ISO 10014 ISO

10013 (!)


ISO Central Secretariat

TCTC

SC

WG

11.950 ISO Standards

556 SCs

187 TCs

1.967 WGs

743 Sekretariate

aus 41 Ländern

~ 7.000 Aktive Projekte

Organisation der internationalen Normung


Den Anwendungsbereich eines TC festlegen

Es wird nur genormt, was sich in das Arbeitsgebiet eines TC einordnen lässt

Die interessierte nationale Normenorganisation legt einen Vorschlag vor, der den Titel, den Anwendungsbereich, das Ziel,

eine Begründung und einen Projektplan enthält (NWIP).nur, wenn diese Voraussetzungen erfüllt sind, beginnt ein Normenprojekt

Die Vollmitglieder (FM) stimmen über das Projekt ab und bekunden ihre Bereitschaft, Experten zu entsenden.

Nur die kontinuierliche Teilnahme beitet eine realistische Möglichkeit, das Endergebnis zu beeinflußen.

Vorgehensweise


Aufbau des TC 176

TC 176Canada

SC 2 Großbritanien

SC 3 Niederlande

9000 10000 – Reihe

WG 18USA

TF x

TF y

SC 1 Frankreich

WG 1GB

WG 2USA

WG 3IR

9001, 9004

WG 9GB

WG 11USA

WG 13IR

WG 12GB


Aufbau des deutschen Spiegelgremiums

NQSZ 1 Obm.: Dipl.-Ing. Menacher

stellvtr. Obm.: Dipl.-Ing. Jürgen Jacob

NWSZ 1.5 Obm.: Dipl.-Ing. Nissl

stellvtr. Obm.: Dipl.-Ing. Menacher

NWSZ 1.6 Obm.: Dipl.-Ing. Köck

stellvtr. Obm.: Dr Bünting

Kernnormen 9000, 9001, 9004, , Interpretationen,

Übergangsdokumente, IWA‘s10000 – Reihe, 19011

16

The ISO 9000 Standards

What’s New for 2009?

17

Contents

Rationale for updatesThe ISO Standards development processScope of changes

ISO 9001ISO 9004

TimetableContact details

18

Rationale for updates……..ISO Review process:

Requires continual review to keep standards up to date. Must be initiated within 5 years of publication of the standard.

User inputs:Global user questionnaire/surveyMarket Justification StudySuggestions arising from the interpretation process.Opportunities for increased compatibility with ISO 14001

Current trends:Keeping up with recent developments in management system practices.

19

The ISO standards developmentprocess

VERIFICATION

USER NEEDS

PREPARATION

SPECIFICATIONS

WDs CD1 CD2 DIS FDIS

VALIDATION

PROJECTS IS

20

Next generation of “ISO 9000”Summary:

ISO 9000:2005 already published – no major changes expected for 2009Current plan is for small changes to ISO 9001 (“amendment”)More significant changes to ISO 9004 (“revision”)

Design specifications for ISO 9001 and ISO 9004 approved by ISO/TC176/SC2 in Sept 2005.Committee Drafts are currently being circulated for comment by ISO/TC176/SC2 members

21

ISO 9001:2009

22

ISO 9001

Main objectives of ISO 9001:2009:to provide greater clarity and ease of use

incorporate improvements to address the interpretations and clarifications requested by users through the ISO/TC176 Interpretations Process

to improve compatibility with ISO 14001:2004

23

What do we mean by “Amendment” to ISO 9001?

No formal ISO distinction between a “revision” and an “amendment”Aim is to emphasize that no MAJOR changes to the requirements are expected for ISO 9001

Focus is on changes that improve clarity, translatability, and ease of use; address ambiguities that resulted in requests for interpretations; improve consistency with the ISO 9000 Family, and improve compatibility with ISO 14001:2004,

24

Impacts and benefits

Amendment to ISO 9001 will focus on high benefit / low impact improvementsSome high benefit / high impact improvements will be saved for the next revision cycle Criteria for assessing impact …

25

Key Inputs for the AmendmentISO/TC 176 approved interpretations, The ISO 9001:2000 Introduction & Support Package set of documents.Systematic Reviews conducted on ISO 9001:2000 and ISO 9004:2000 Web based User Feedback Survey conducted by ISO/TC 176/SC2ISO 14001:2004, ISO Guide 72:2001, Guidelines for the justification and development of management system standards – Market Justification Study

26

Interpretations Process

37 Official TC176 Interpretations published on ISO website

See www.tc176.org/ for detailsImportant source of input for ISO 9001:2009

Some interpretation requests indicate need for clarification

http://www.tc176.org/

27

The ISO 9000:2000 Support Package / Guidance documents

Documentation requirementsThe process approachApplication of ISO 9001:2000 (“Permissible Exclusions”)Guidance on “Outsourcing”Available from www.iso.org

http://www.iso.ch/

28

Results of User Survey (2003)

Responses from 941 users in 63 countries. 1477 individual comments All four ISO 9001:2000 product categories (Hardware, Software, Processed Materials and Services) well represented.Approx 80% of respondents were satisfied with the ISO 9001:2000 standard.

29

337

7058

453932

28

25

20

229

58

UNITED STATESCHINAGERMANYUNITED KINGDOMMEXICOJAPANCANADACOLOMBIAAUSTRALIAITALYOther

Survey responses

30

Size of organization

271

377

290

3

small

medium

large

Blank

31

How long certified?

250

424

264

30

50100150200250300350400450

0-3 4-10 10+ BlankYEARS

32

How well does ISO 9001:2000 meet your needs?

137

565

14

167

16 42Excellent

Good

No comment (or NOTAPPLICABLE)Needs to be improved

Not adequate

Blank

33

Are you happy with the process approach?

849

22

70YesNoBlank

34

Most commented clauses / areas of confusion…..…

813 (55%) of total 1477 comments related to:4.1 General requirements4.2 Documentation6.2 Human resources7.3 Design and development7.5 Production and Service Provision8.2 Monitoring and Measurement8.5 Improvement

35

Key strategies for ISO 9001:2009……..

ISO 9001:2000 Process Approach model will be maintainedThe standard will remain generic and be applicable to all sizes and types of organization operating in any sector.Compatibility with ISO 14001:2004 to be maintained and if possible enhancedConsistency with the revision of ISO 9004:2000 will be maintainedChanges will be restricted to limit impact on users

36

Key strategies for ISO 9001:2009…….. (Continued)

The ISO 9001:2000 support package will be used to assist the writers to identify issues needing clarification.Ambiguities requiring formally produced interpretations will be addressedChanges only introduced where there are clear benefitsDrafts of the amended standard will be subjected to verification against the design specification, and to validation by users

37

Maintaining the “Consistent Pair” of QMS standards

The ‘consistency’ between the amendment of ISO 9001:2000 and the revision of ISO 9004:2000 means:

lack of conflict between the standards,the standards fit well together, but are able to stand alone,harmonized concepts and terminology,easy transition from one standard to the other,the two standards can be readily applied within the same quality management system.each standard will have a structure that best meets the needs of its users

38

Compatibility with ISO 14001“Compatibility” means that common elements of the standards can be implemented by organizations in a shared manner, in whole or in part, without unnecessary duplication or the imposition of conflicting requirements. When maintaining compatibility with ISO 14001:2004 the following do not necessarily represent potential conflicts:

Different text in common elements or terminologyDifferent numbering of the clausesDifferent models and structureInclusion of guidance, notes or annexes

39

Compatibility with Sector specific and other standards

Sector standards based on ISO 9001:2000Example ISO/TS 16949; TL 9000

Other management system standards that are based on ISO 9001:2000 and use its structure and text.

40

Other decisions already made for ISO 9001:2009 …..…

The current scope, purpose, title and field of application of the standard will be unchanged.The 8 Quality Management Principles (as contained in ISO 9000:2005) will be applied, unchanged.

41

ISO 9004:2009

42

Purpose of ISO 9004:2009……

“To help organizations who are users of ISO 9001 obtain sustained benefit from the implementation of a more broad-based and in-depth quality management system”.

43

Objectives for ISO 9004:2009Facilitate improvement in users’ quality management systemsProvide guidance to an organization for the creation of a quality management system that:

creates value for its customers, via the products it providescreates value for all other interested parties, balances all interested-party viewpoints.

Provide guidance for managers on leading their organization towards sustainable success.Forward compatibility to allow organizations to build on existing quality management systems.

44

Target customers forISO 9004:2009

First PriorityCurrent users of ISO 9001:Organizations just getting started on ISO 9001

Second PriorityOrganizations who are not users of ISO 9001 who want to go farther in QMS implementation than 9001

45

ISO 9004:2009 is notnot intended to be:

An implementation guide to ISO 9001A business excellence modelA set of requirements A textbook on Total Quality ManagementA source of untried approaches and methods

46

“Guiding Principles” for ISO 9004:2009

Continue to use the “eight Quality Management Principles”, but also take into account:

Ethics /social aspectsMission and Vision of the organization Adaptability / agility (ability to respond to changing opportunities / threats).Management of knowledge. Alignment with other management systemsLinking objectives and actions to results.

Concept of the “Consistent Pair” (ISO 9001 and 9004) to be maintained, but with more flexible criteria for “consistency”

47

Schedule (ISO 9001 and 9004)2004 – User survey results received and analyzed; systematic review performed2005 – Design specs approved2006/2008 – Drafting and consensus process2009 – Publication2009/2010 – Transition period for ISO 9001 certification

To be defined by ISO and IAF (likely to be 18 months)

48

For further information:

ISO web site www.iso.orgYour National Standards BodyISO Liaison Member web sites ISO/TC176/SC2 websiteISO Management Systems magazineISO Press releases

http://www.iso.org/


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Documents

Wie entstehen Normen? die Revision der ISO 9000-Familie · Folie 2 - 05/07 die Revision der ISO 9000-Familie Dipl.-Ing.(FH) Olaf Stuka, DGQ-Regional • gemeinnützig und unabhängig